CN112656869A - New composition for treating lung heat cough and asthma, preparation method and application - Google Patents
New composition for treating lung heat cough and asthma, preparation method and application Download PDFInfo
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Abstract
The invention provides a new composition for treating lung heat cough and asthma and a preparation method and application thereof, the traditional Chinese medicine composition comprises or consists of 4-8 parts by weight of fried cortex mori radicis extract, 1-3 parts by weight of honey-fried licorice root extract and 2-6 parts by weight of baked cortex lycii radicis extract, wherein in the composition, the mulberroside A is not less than 18mg/g, the lycium barbarum extract is not less than 12mg/g, the liquiritin is not less than 1.8mg/g and the glycyrrhizic acid is not less than 3.5 mg/g. The composition can clear lung heat and treat cough and asthma, in particular to treat cough and asthma of children.
Description
Technical Field
The invention relates to the field of medicines, in particular to a novel composition for treating lung heat cough and asthma, a preparation method and application thereof.
Background
The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.
Xiebai san (Children's medicine syndrome directly know formula) from northern Song Qian second is a classic prescription for treating children's lung heat cough and asthma, and is composed of cortex Mori, cortex Lycii, and Glycyrrhrizae radix. Both cortex mori radicis and cortex lycii radicis are stir-fried products, the bitter and cold properties of the cortex mori radicis and the cortex lycii radicis can be relieved by frying, and the liquorice honey-fried products can enhance the efficacy of moistening lung to arrest cough and strengthen the spleen and stomach to achieve the prominent effect of regulating the middle warmer. Ming Dynasty Li Shizhen means that this formula is the guideline for purging the lung. The cortex mori radicis a monarch drug in the formula, is sweet and pungent in taste and cold in nature, and has the effects of clearing lung heat, relieving asthma and stopping cough; cortex lycii radicis is sweet and cold in nature, can purge latent fire in lung, has the effect of nourishing yin, and is used as a ministerial drug; the liquorice and the polished round-grained rice are sweet in taste and neutral in nature, can moderate the cold property of the two medicinal materials of the cortex mori radicis and the cortex lycii radicis and serve as adjuvant and guiding medicaments, and the combination of the medicinal materials has the effect of treating both symptoms and root causes.
Cortex Mori has effects in purging lung, relieving asthma, inducing diuresis, and relieving edema, and can be used for treating cough and asthma due to lung heat, edema of face, and dysuresia; the effective component is a flavonoid compound, which mainly comprises: morusin, phellandrene, cyclosporine, morusin, cyclosporine, phellinus igniarius ketone, morusin and the like. The cortex lycii radicis mainly contains alkaloids, organic acid compounds and the like, wherein the kukoamine A and the kukoamine B can block the inflammatory activation of cells from the source in vitro, avoid the immune response disorder and play an antagonistic role on lipopolysaccharide and CpG DNA in vivo. The main effective components of radix Glycyrrhizae Preparata are flavonoids and triterpenes, such as glycyrrhizic acid and liquiritin; the glycyrrhizic acid has antitussive, expectorant, antiasthmatic, lung protecting and pulmonary fibrosis resisting effects.
Disclosure of Invention
The original formula of Xiebai san is recorded in the Zheng Zhi Jue (Song and Qian second) of Xiao Bai san, two root bark of Chinese wolfberry (washed and baked), white mulberry root bark (fried to yellow) and licorice root (fried) with one coin. The powder is added, one bunch of polished round-grained rice and two small pieces of water are added, and the decoction is carried out for seven minutes and is taken before eating. However, the actual operation process, parameters and key control points of the decoction are not described in detail, too much randomness exists, the decoction is influenced by a plurality of factors, and in order to better improve the randomness and better exert the drug effect of the ancient prescription, the invention provides the Xinxiebai powder composition for treating the lung heat cough and asthma and the preparation method thereof, and provides a certain reference standard for controlling the dosage of the mulberry bark glycoside A, the lycium bark B, the liquiritin and the glycyrrhizic acid in the Xinxiebai powder composition.
In a first aspect of the present invention, the present invention provides a Chinese medicinal composition comprising or consisting of: 4-8 parts of fried cortex mori extract, 1-3 parts of honey-fried licorice extract and 2-6 parts of baked cortex lycii radicis extract, wherein in the composition, the mulberroside A is not less than 18mg/g, the lycium barbarum B is not less than 12mg/g, the liquiritin is not less than 1.8mg/g and the glycyrrhizic acid is not less than 3.5 mg/g. For convenience of presentation, the Chinese medicinal composition of the first aspect of the invention is simply referred to as new Xiebai powder composition.
In an embodiment of the present invention, the fried cortex mori radicis extract is a fried cortex mori radicis ethanol extract, the honey-fried licorice extract is a honey-fried licorice ethanol extract, and the baked cortex lycii radicis extract is a baked cortex lycii radicis water extraction and alcohol precipitation extract.
The Chinese medicine element has the theory that the secret which is not transmitted by the traditional Chinese medicine lies in the dosage, and people have realized that the examination and the verification of the dosage are particularly key to the curative effect of the medicine from the beginning of the ancient times. According to the record of the original prescription of Xiebai san, ten times of dosage of cortex lycii radicis and cortex mori radicis are required to be added into liquorice, and japonica rice is required to be used as adjuvant. On the contrary, the inventor finds in research that the combination of the fried cortex mori ethanol extract, the roasted radix glycyrrhizae ethanol extract and the roasted cortex lycii water extraction and alcohol precipitation extract by 4-8 parts, 1-3 parts and 2-6 parts by weight respectively cannot better coordinate the drug properties of the medicinal materials, exert the functions of the cortex mori monarch drug, the cortex lycii ministerial drug and the radix glycyrrhizae conductant drug, and achieve the effect of treating both symptoms and root causes, compared with the original prescription, the compound preparation can not only effectively prolong the incubation period of cough and inhibit the cough frequency to achieve more excellent cough relieving effect, but also can obviously prolong the asthma incubation period to achieve more excellent asthma relieving effect.
In a second aspect of the present invention, the present invention provides a method for preparing the Chinese medicinal composition described in the first aspect, which comprises: respectively processing cortex Mori, cortex Lycii and Glycyrrhrizae radix to obtain parched cortex Mori, baked cortex Lycii and radix Glycyrrhizae Preparata; taking 10-15 parts by weight of fried white mulberry bark to prepare a fried white mulberry bark extract, taking 10-15 parts by weight of roasted cortex lycii radicis to prepare a roasted cortex lycii radicis extracting solution, and taking 1-2 parts by weight of honey-fried licorice root to prepare a honey-fried licorice root extract; and then combining the three extracts in proportion to obtain the traditional Chinese medicine composition.
In some embodiments of the present invention, the processing process of parching cortex mori radicis comprises: washing cortex Mori with water, moistening with water, slicing, air drying, parching, and spreading for cooling; wherein the frying temperature is preferably 110-.
In one or more embodiments of the present invention, the processing process of parching cortex mori radicis comprises: taking white or light yellow white cortex mori which has flat outer surface and thickness not less than 3mm, and soaking and washing with 10 times of water for 30s each time until the color of the water is not changed any more. Adding 0.2 times of water into the washed cortex Mori, and moistening for 1 hr. Cutting into 5-10 mm wide threads, spreading out, and air drying to obtain cortex mori decoction pieces; taking cortex Mori decoction pieces, placing in a stir-frying container, stir-frying at 110-.
In some embodiments of the present invention, the processing of cortex lycii radicis comprises: washing fresh cortex Lycii with water, filtering with coarse cloth, washing, slicing to obtain cortex Lycii decoction pieces, and drying; wherein the drying condition is preferably 30-50 deg.C and 30-50% humidity. In particular, 45 ℃ and 40% humidity are preferred.
In one or more embodiments of the present invention, the processing process of cortex lycii radicis comprises: taking a fresh cortex lycii radicis medicinal material which is 8-12cm long and 1.5-2cm in cylinder diameter and is uniform and orderly, adding 15 times of water, stirring for 20 seconds by using a large hair brush, filtering and washing the water by using coarse gauze for 4 times, and then cutting into cortex lycii radicis decoction pieces which are 3-10 cm long and 0.5-1.5 cm wide; drying at 45 deg.C and 40% humidity.
In some embodiments of the invention, the processing process of the honey-fried licorice root comprises the following steps: moistening Glycyrrhrizae radix with water, slicing, air drying, adding refined honey, stirring, moistening, parching to yellow to dark yellow, taking out when it is not sticky, and air cooling; wherein the refined honey is diluted with water at a ratio of 1:1 for use, and is moistened and moistened for 30min, and the mixture of refined honey and medicinal materials is preferably 1:4, and the parching temperature is 80-120 deg.C, and the parching time is 40 min.
In one or more embodiments of the invention, the processing technology of the honey-fried licorice root comprises the following steps: taking liquorice with the length of 15-60 cm, the diameter of the top end of more than 1.6cm and the diameter of the tail end of more than or equal to 1cm, adding 2.5 times of water, moistening for 48 hours, cutting into 2-4mm thick slices, and airing; diluting the refined honey with water at a ratio of 1:1, adding the refined honey of 1/4, stirring, moistening for 30min, parching at 80-120 deg.C for 40min to yellow to dark yellow, taking out when it is not sticky, and cooling.
In the processing method of traditional Chinese medicine, moistening, also called as Fu or stuffiness, belongs to the category of water preparation method. The purpose is as follows: on the premise of no loss or little loss of effective components of the medicine, clear water or liquid auxiliary materials slowly permeate into the tissues of the medicinal materials, so that the decoction quality is improved after the medicinal materials absorb a considerable amount of water. The stuffiness and wetness can affect the quality of the medicinal materials, so the play of the drug effect is directly related. For example, Chenjia Mo in Ben Cao Meng quan (herbal medicine) of Chen Jia Mo is moderate in price, so that the effect is difficult to obtain, and if too much, the smell is lost, which is not the sense of smell, but refers to the property and effect of herbs. In the processing method, the inventor intensively studies the moistening time to enable the moistening time to be moderate, for example, taking the cortex mori as an example, the invention adopts the cortex mori radicis medicinal material with the diameter not less than 3mm to be moistened for 1 hour after being cleaned, compared with the existing guidance aiming at moistening the cortex mori radicis for 4 to 8 hours with the diameter of 2 to 4mm, the invention not only greatly shortens the processing time, but also finds that the moistening effect of 1 hour is more beneficial to slicing and frying the medicinal material at the later stage and obtaining the effective component (such as the mulberroside A) in the extract. For example, in the treatment of liquorice, the liquorice is subjected to moistening for 2 times, the liquorice is sliced and dried after being moistened for 48 hours for the first time, the liquorice is moistened for 30 minutes after being uniformly mixed with honey and water for the second time, and the heating operation is not needed in the two moistening processes.
The present invention provides a method for obtaining extracts of sauted cortex mori, honey-fried licorice root and roasted cortex lycii radicis. Wherein the taking and measuring relations of the fried white mulberry bark, the roasted liquorice and the roasted cortex lycii radicis are as follows: 10-15 parts of cortex mori (fried), 10-15 parts of cortex lycii (baked) and 1-2 parts of liquorice (roasted). In some embodiments of the present invention, the measurement relationship is: 12 parts of cortex mori (fried), 12 parts of cortex lycii (baked) and 2 parts of liquorice (roasted).
In some embodiments of the present invention, the preparation method of the parched cortex mori extract comprises: pulverizing parched cortex Mori into 0.3-0.5cm coarse particles, adding 70% ethanol, reflux-extracting for 2 times, adding 6-10 times of 70% ethanol for the first time, heating to boil, maintaining slight boiling at 80-100 deg.C for 1-2 hr, filtering, adding 4-8 times of 70% ethanol for the second time, heating to boil, maintaining slight boiling at 80-100 deg.C for 0.5-1.5 hr, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying.
In some embodiments of the present invention, the method for preparing a honey-fried licorice extract comprises: taking radix Glycyrrhizae Preparata, coarsely crushing into coarse particles of 0.3-0.5cm, adding 50% ethanol, reflux-extracting for 2 times, adding 6-10 times of 50% ethanol for the first time, heating to boil, keeping slight boiling at 90-120 deg.C for 1-2h, filtering, adding 6-8 times of 50% ethanol for the second time, heating to boil, keeping slight boiling at 90-120 deg.C for 0.5-1.5h, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying.
In some embodiments of the present invention, the method for preparing the extract of cortex lycii radicis comprises: taking cortex lycii radicis to be coarsely broken into coarse particles, adding water for reflux extraction for 2 times, adding 8-12 times of water for heating reflux for 1-2h for the first time, filtering, adding 6-10 times of water for heating reflux for 0.5-1.5h for the second time, filtering, combining filtrates, concentrating under reduced pressure at 50-65 ℃ until the specific gravity is 1.10-1.15 (measured at 50 ℃), placing at room temperature, adding 3 times of ethanol, stirring for 0.5h, standing for 12h, taking supernatant, recovering ethanol, continuously concentrating until the specific gravity is 1.05-1.08 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, and drying to obtain the traditional Chinese medicine.
Mixing 4-8 parts by weight of fried cortex mori extract, 1-3 parts by weight of honey-fried licorice extract and 2-6 parts by weight of baked cortex lycii radicis extract to obtain the traditional Chinese medicine composition, wherein in the traditional Chinese medicine composition, the mulberroside A is not less than 18mg/g, the lycium barbarum extract is not less than 12mg/g, the liquiritin is not less than 1.8mg/g and the glycyrrhizic acid is not less than 3.5 mg/g.
In a third aspect of the present invention, there is provided a pharmaceutical formulation comprising as an active ingredient the composition of the senna powder as described in the first aspect above.
The Chinese medicinal composition of the present invention can be administered in a unit dosage form. The dosage form for administration may be a liquid dosage form, a solid dosage form, and the like. Such as tablets, capsules, pills, aerosols, pills, powders, solutions, suspensions, granules, etc. In some embodiments of the invention, the pharmaceutical formulation is an oral liquid, a pellet, a granule, a tablet, or the like.
The pharmaceutical preparation related to the invention contains the novel Xiebai powder composition and one or more pharmaceutical excipients. Some embodiments of the invention include methods of producing a pharmaceutical formulation comprising mixing the novel purgative composition of the invention with a pharmaceutical excipient. It is usually prepared by uniformly mixing the novel purgative composition with liquid and/or finely divided solid auxiliary materials in the desired ratio and then, if necessary, shaping the resulting mixture into the desired shape.
Conventional adjuvants such as excipients, for example binders, fillers, acceptable wetting agents, tableting lubricants and disintegrating agents, can be used in tablets and capsules for oral administration. Liquid preparations for oral administration may be, for example, solutions (such as oral liquids), emulsions, aqueous suspensions, oily suspensions, syrups, and the like. Alternatively, oral formulations may be in the form of a dry powder which may be reconstituted with water or another suitable liquid vehicle prior to use. Other adjuvant additives such as suspending agents, emulsifying agents, non-aqueous vehicles (including edible oils), preservatives, flavoring and coloring agents and the like may be added to the liquid preparations.
The Chinese medicinal composition of the present invention can be prepared into preparations by using known techniques by those skilled in the art, and of course, suitable pharmaceutical excipients other than those mentioned in the present invention can be known in the art, for example, see handbook of pharmaceutical excipients (4 th edition).
In some embodiments of the invention, the invention provides an oral liquid comprising or prepared from the following raw materials: 7-15 wt% of the new Xiebai powder composition, 0.1-0.2 wt% of anhydrous citric acid, 0.009-0.015 wt% of neotame and 85-92 wt% of water, wherein the sum of the weight percentages of the raw materials is not more than 100%.
The invention provides a method for preparing the oral liquid, which comprises the following steps: mixing the Xinxiebai powder composition, anhydrous citric acid, neotame and purified water uniformly according to the dosage, filtering with a plate and frame filter or with a 0.5-0.8 μm microporous filter membrane, sterilizing, and bottling to obtain the oral liquid.
In some embodiments of the present invention, the present invention provides a pellet comprising or prepared from the following raw materials: 35-45 wt% of the new Xiebai powder composition, 25-40 wt% of microcrystalline cellulose and 10-25 wt% of sodium carboxymethyl starch, wherein the sum of the weight percentages of the raw materials is not more than 100%.
The invention provides a method for preparing a pellet, which comprises the following steps: mixing the Xinxiebai composition, microcrystalline cellulose and sodium carboxymethyl starch uniformly according to the using amount, sieving by a 100-mesh sieve, adding 60-75% ethanol to prepare a soft material, putting the prepared soft material into an extruder, and extruding at a certain extrusion speed through a sieve pore with the diameter of 0.5mm, wherein the extrusion rotating speed is 30 Hz; rounding: adding the extrudate into a spheronizer, adjusting the rotating speed and the spheronization time, and gradually rolling into a spherical shape, wherein the spheronization rotating speed is 35Hz, and the spheronization time is 3-8 min; and (3) drying the pellets: adding the obtained material into bottom spray granulating chamber of fluidized bed, starting fluidized bed granulating and coating machine, adjusting air inlet frequency to 30Hz and air inlet temperature to 45-60 deg.C, and drying for 5-15 min.
In some embodiments of the invention, the invention provides a granule comprising or prepared from the following raw materials: 60-80 wt% of the new Xiebai powder composition and 20-40 wt% of a 10% sucrose aqueous solution, wherein the sum of the weight percentage of the raw materials is not more than 100%.
The invention provides a method for preparing granules, which comprises the following steps: taking the new Xiebai powder composition and a 10% sucrose aqueous solution, adopting a fluidized bed type boiling granulator, and setting parameters as follows: the frequency of a fan is 35Hz, the air inlet temperature is 70 ℃, the material temperature is 45-50 ℃, the rotation speed of a peristaltic pump is 2-5rpm, after the sucrose aqueous solution is completely sprayed, the peristaltic pump is closed, and the drying is continued for 10-15min, thus obtaining the particles.
In some embodiments of the present invention, the present invention provides a tablet comprising or prepared from the following raw materials: 30-48 wt% of the novel Xiebai powder composition, 20-35 wt% of xylitol, 25-40 wt% of sugar powder and 0.5-1 wt% of magnesium stearate, wherein the sum of the weight percentages of the raw materials is not more than 100%.
The present invention provides a method of preparing a tablet comprising: mixing XINXIEBAISAN composition, xylitol, sugar powder, and magnesium stearate, and tabletting.
In a fourth aspect of the present invention, there is provided a use of the xiexingbaisan composition according to the first aspect or the pharmaceutical preparation according to the third aspect in the preparation of a medicament for treating cough and asthma due to lung heat. In particular, the new Xiebai powder composition or the medicament thereof can clear lung heat and treat infantile cough and asthma, and the preparations such as oral liquid, granules, pellets and the like are particularly suitable for children.
Compared with the prior art, the invention has the following advantages: the invention adopts a brand new process and dosage to improve the original prescription of the Xiebai powder, reduces the use of the drug-containing polished round-grained rice and increases the dosage of the liquorice, and combines the processing and extraction processes of the invention, so that the Xiebai powder composition can obviously prolong the latent period of cough and the latent period of induced asthma and obviously inhibit the frequency of cough and better play the roles of relieving cough and relieving asthma on the basis of playing the role of the original prescription in treating cough with lung heat. In addition, the invention definitely specifies the dosage of the cortex mori glycoside A, the lycium barbarum extract, the liquiritin and the glycyrrhizic acid in the Xinxiebai composition, can better control the quality of the medicine, and provides a certain reference standard for medicine evaluation.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the application and, together with the description, serve to explain the application and are not intended to limit the application. Embodiments of the invention are described in detail below with reference to the attached drawing figures, wherein:
FIG. 1: a is a liquid chromatogram of the mulberroside A standard product in example 6, and B is a liquid chromatogram of a Xinxiebai composition test sample.
FIG. 2: a is a liquid chromatogram of the liquorice mixed standard product in example 6, and B is a liquid chromatogram of a Xinxiebai composition test sample.
FIG. 3: a is the liquid chromatogram of the lycium barbarum extract standard in example 6, and B is the liquid chromatogram of the Xinxiebai powder composition sample.
Detailed Description
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out according to conventional conditions or according to conditions recommended by the manufacturers.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The reagents or starting materials used in the present invention can be purchased from conventional sources, and unless otherwise specified, the reagents or starting materials used in the present invention can be used in a conventional manner in the art or in accordance with the product specifications. In addition, any methods and materials similar or equivalent to those described herein can be used in the methods of the present invention. The preferred embodiments and materials described herein are intended to be exemplary only.
The processing of traditional Chinese medicine is a pharmaceutical technology which is also called as stir-frying, repairing or repairing and treating according to the theory of traditional Chinese medicine and according to different requirements of medical treatment, blending and preparation and the properties of medicinal materials. Has close influence on the property of the Chinese medicine, the chemical components and the clinical curative effect of the Chinese medicine. For example, the importance of the processing in Song Dynasty "Taiping Sheng Hui Fang" recorded that the processing lost its sex, screened out Rou and different dosage forms, although the name of disease treatment, never cured, so it is necessary to pay special attention to the medical personnel. "in addition, as known in the art, the main purposes and effects of processing Chinese herbs include, but are not limited to: adverse reactions of the medicine are reduced or eliminated, and the safety of the medicine is guaranteed; the medicine property and the function are changed, and the clinical curative effect is enhanced; the preparation is convenient to prepare, and the quality of the medicine is ensured; the bad smell is changed, and the medicine is convenient to take; is convenient for storage and drug effect preservation; change the action tendency of the medicine or enhance the action tendency of the medicine, and the like. After different processing treatments, the chemical components of the drug can change differently, and the changes mainly relate to decomposition, isomerization, oxidation, replacement, decomposition, condensation and the like. These changes may lead to enhanced or reduced solubility and leaching of the chemical components and/or to the formation of new chemical components, which may have the effect of causing a change or increase or decrease in the therapeutic efficacy of the drug, or the toxicity, severity and side effects of the drug, etc. or increase or decrease, resulting in a change in the properties of the drug.
The invention provides a processing technology for the medicinal materials with the formula, which is safe and effective, can exert the curative effect to the maximum extent and simultaneously reduce and eliminate the toxic and side effects to the maximum extent, and the processing technology of the invention is as follows, and if no special description exists, the medicinal materials in the implementation mode of the invention all adopt the processing mode:
parching cortex Mori: taking white or light yellow white cortex mori which has flat outer surface and thickness not less than 3mm, and soaking and washing with 10 times of water for 30s each time until the color of the water is not changed any more. Adding 0.2 times of water into the washed cortex Mori, and moistening for 1 hr. Cutting into 5-10 mm wide threads, spreading out, and air drying to obtain cortex mori decoction pieces; taking cortex Mori decoction pieces, placing in a stir-frying container, stir-frying at 110-.
Cortex lycii radicis (baked): taking a fresh cortex lycii radicis medicinal material which is 8-12cm long and 1.5-2cm in cylinder diameter and is uniform and orderly, adding 15 times of water, stirring for 20 seconds by using a large hair brush, filtering and washing the water by using coarse gauze for 4 times, and then cutting into cortex lycii radicis decoction pieces which are 3-10 cm long and 0.5-1.5 cm wide; drying at 45 deg.C and 40% humidity.
Licorice (roasted): taking liquorice with the length of 15-60 cm, the diameter of the top end of more than 1.6cm and the diameter of the tail end of more than or equal to 1cm, adding 2.5 times of water, moistening for 48 hours, cutting into 2-4mm thick slices, and airing; diluting the refined honey with water at a ratio of 1:1, adding the refined honey of 1/4, stirring, moistening for 30min, parching at 80-120 deg.C for 40min to yellow to dark yellow, taking out when it is not sticky, and cooling.
After the processing technology disclosed by the invention is used for processing, the components of the mulberry bark glycoside A, the lycium bark B, the liquiritin and the glycyrrhizic acid in the medicinal materials and the leaching in the subsequent technology can be ensured to the greatest extent.
In addition, the present invention is different from the original formula of Xiebai san, namely, according to the records of Xiao Er Yao Zheng Zhi Jue, cortex lycii radicis (washed and baked), cortex mori radicis (fried and fried to yellow) one by two, and licorice root (fried) one by one. The powder is added, one bunch of polished round-grained rice and two small pieces of water are added, and the decoction is carried out for seven minutes and is taken before eating. The invention relates to a novel Xiebai powder composition which is obtained by compounding a fried mulberry bark ethanol extract, a honey-fried licorice root ethanol extract and a cortex lycii radicis water extraction and alcohol precipitation extract, and limits the content of key chemical components in the composition, wherein, the mulberry bark glycoside A is not less than 18mg/g, the cortex lycii radicis ethyl is not less than 12mg/g, the liquiritin is not less than 1.8mg/g, and the glycyrrhizic acid is not less than 3.5 mg/g. The Xinxiebai powder composition has definite curative effect, clear and definite process and convenient implementation.
The extraction method of the extract provided by the embodiment of the invention is implemented as follows, unless otherwise specified:
wherein, the taking amount of the cortex mori (fried), the liquorice (roasted) and the cortex lycii radicis (baked) when the extract is prepared is as follows: 10-15 parts of cortex mori (fried), 10-15 parts of cortex lycii (baked) and 1-2 parts of liquorice (roasted).
The preparation method of the fried mulberry bark ethanol extract comprises the following steps: pulverizing parched cortex Mori into 0.3-0.5cm coarse particles, adding 70% ethanol, reflux-extracting for 2 times, adding 6-10 times of 70% ethanol for the first time, heating to boil, maintaining slight boiling at 80-100 deg.C for 1-2 hr, filtering, adding 4-8 times of 70% ethanol for the second time, heating to boil, maintaining slight boiling at 80-100 deg.C for 0.5-1.5 hr, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying.
The preparation method of the honey-fried licorice root ethanol extract comprises the following steps: taking radix Glycyrrhizae Preparata, coarsely crushing into coarse particles of 0.3-0.5cm, adding 50% ethanol, reflux-extracting for 2 times, adding 6-10 times of 50% ethanol for the first time, heating to boil, keeping slight boiling at 90-120 deg.C for 1-2h, filtering, adding 6-8 times of 50% ethanol for the second time, heating to boil, keeping slight boiling at 90-120 deg.C for 0.5-1.5h, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying.
The preparation method of the cortex lycii radicis water extraction and alcohol precipitation extract comprises the following steps: taking cortex lycii radicis to be coarsely broken into coarse particles, adding water for reflux extraction for 2 times, adding 8-12 times of water for heating reflux for 1-2h for the first time, filtering, adding 6-10 times of water for heating reflux for 0.5-1.5h for the second time, filtering, combining filtrates, concentrating under reduced pressure at 50-65 ℃ until the specific gravity is 1.10-1.15 (measured at 50 ℃), placing at room temperature, adding 3 times of ethanol, stirring for 0.5h, standing for 12h, taking supernatant, recovering ethanol, continuously concentrating until the specific gravity is 1.05-1.08 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, and drying to obtain the traditional Chinese medicine.
The three extracts prepared by the process are compounded according to 4-8 parts by weight of fried white mulberry root-bark extract, 1-3 parts by weight of honey-fried licorice root extract and 2-6 parts by weight of baked cortex lycii radicis extract to obtain the medicinal composition of the Xinxiebai powder.
Example 1
The taking amount of the cortex mori radicis (fried), the liquorice (roasted) and the cortex lycii radicis (baked) is as follows: 10-15 parts of cortex mori (fried), 10-15 parts of cortex lycii (baked) and 1-2 parts of liquorice (roasted).
Parched cortex Mori ethanol extract: taking 300g of fried cortex mori radicis decoction pieces with white or light yellow outer surface, flatness and thickness not less than 3mm after being processed, roughly crushing the decoction pieces into coarse particles with the particle size of 0.3-0.5cm, adding 70% ethanol for reflux extraction for 2 times, adding 8 times of 70% ethanol for the first time, heating to boil, keeping slight boiling at 95 ℃ for 1.5h, filtering, adding 6 times of 70% ethanol for the second time, keeping slight boiling at 95 ℃ for 1h, filtering, merging filtrate, recovering ethanol, continuously concentrating until the specific gravity is 1.06 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, and drying to obtain 60g of extract.
And (3) honey-fried licorice root ethanol extract: taking 50g of prepared liquorice root with the length of 15-60 cm, the diameter of the top end of more than 1.6cm and the diameter of the tail end of more than or equal to 1cm, coarsely breaking the liquorice root into coarse particles with the diameter of 0.3-0.5cm, adding 50% ethanol for reflux extraction for 2 times, adding 10 times of 50% ethanol for the first time, heating to boil, keeping slight boiling at 110 ℃ for 1.5h, filtering, adding 8 times of 50% ethanol for the second time, heating to boil, keeping slight boiling at 110 ℃ for 1h, filtering, merging filtrate, recovering ethanol, continuously concentrating until the specific gravity reaches 1.05-1.08 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, and drying to obtain 12g of extract.
Water extraction and alcohol precipitation extract of cortex lycii radicis: taking 300g of processed cortex lycii radicis decoction pieces which are 8-12cm long and have uniform and neat cylinder diameter of 1.5-2cm, adding water for reflux extraction for 2 times, adding 10 times of water for heating reflux for 1.5h for the first time, filtering, adding 8 times of water for heating reflux for 1h for the second time, filtering, combining filtrates, concentrating at 60 ℃ under reduced pressure until the specific gravity is 1.12 (measured at 50 ℃), standing at room temperature, adding 3 times of ethanol, stirring for 0.5h, standing for 12h, taking supernatant, recovering ethanol, continuously concentrating until the specific gravity is 1.06 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, drying to obtain 40g of extract.
Mixing the above extracts to obtain new XIEBAISAN composition.
Example 2
Taking 50g of the Xiexiangbaisan composition (prepared by the method of example 1), 0.52g of anhydrous citric acid, 0.05g of neotame and 450ml of purified water, stirring and mixing uniformly, filtering by adopting a 0.6 mu m microporous filter membrane, sterilizing and filling into a bottle of 5ml to obtain the Xiexiangbaisan composition oral liquid.
The application method and the dosage are as follows: the daily dose is recommended to be 2 bottles, and one bottle is taken in the morning and at night.
Example 3
Taking 50g of Xinxiebai composition (prepared by the method of example 1), 44g of microcrystalline cellulose and 30g of sodium carboxymethyl starch, uniformly mixing, sieving by a 100-mesh sieve, adding 60% ethanol to prepare a soft material, putting the prepared soft material into an extruder, and extruding at a certain extrusion speed through a sieve pore with the diameter of 0.5mm, wherein the extrusion speed is 30 Hz; rounding: adding the extrudate into a spheronizer, adjusting the rotating speed and the spheronization time, and gradually rolling into a spherical shape, wherein the spheronization rotating speed is 35Hz, and the spheronization time is 5 min; adding the obtained material into a bottom spraying granulating chamber of a fluidized bed, starting a fluidized bed granulating and coating machine, adjusting air inlet frequency to 30Hz, air inlet temperature to 60 deg.C, material temperature to 45 deg.C, and drying for 10min to obtain 110g of XIEBAISAN micro pill.
The application method and the dosage are as follows: the daily dose is recommended to be 2g, and 1g in the morning and evening respectively, so that the honey water can be taken together for children conveniently.
Example 4
Taking 50g of Xinxiebai powder composition (prepared by the method of example 1) and 20g of 10% sucrose aqueous solution, adopting a fluidized bed type boiling granulator, and setting the parameters as follows: the frequency of a fan is 35Hz, the air inlet temperature is 70 ℃, the material temperature is 45-50 ℃, the rotation speed of a peristaltic pump is 3rpm, after the sucrose aqueous solution is completely sprayed, the peristaltic pump is closed, the drying is continued for 10-15min, the discharging and the granule straightening are carried out, and 50g of the Xiebai san granules are obtained and packaged into 0.5 g/bag.
The application and dosage are as follows: the daily dose is recommended to be 2 bags, one bag in the morning and one bag in the evening.
Example 5
Taking 50g of the Xinxiebai powder composition (prepared by the method of example 1), 27g of xylitol, 33g of sugar powder and 1g of magnesium stearate, uniformly mixing, tabletting and preparing into 0.5 g/tablet to obtain 200 Xinxiebai powder composition tablets.
The application and dosage are as follows: the daily dose is 4 tablets, and the dose is 2 tablets respectively in the morning and at night.
Example 6Content detection of active ingredients in pharmaceutical composition
The effective components of the Chinese medicinal composition in the above example 1 are detected, and the content is determined by high performance liquid chromatography (general rule 0512).
Mulberry bark glycoside A
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; taking methanol as a mobile phase A and 0.1% formic acid solution as a mobile phase B, and carrying out gradient elution according to the following table; the detection wavelength was 325 nm. The number of theoretical plates is not less than 5000 calculated according to the mulberry skin glucoside A peak.
Mobile phase gradient elution table
Preparation of control solutions: taking a proper amount of mulberroside A reference substance, precisely weighing, and adding 60% methanol to obtain a solution containing 0.1mg per 1 mL.
Preparation of a test solution: grinding the Xinxiebai powder composition (sieving with a third sieve), precisely weighing about 0.20g, placing in a conical flask with a plug, precisely adding 20mL of 60% methanol, weighing, standing for 0.5h, performing ultrasonic treatment for 0.5h, cooling, weighing again, supplementing the weight loss with 60% methanol, shaking up, filtering, and taking the subsequent filtrate.
The determination method comprises the following steps: precisely sucking 5 μ L of each of the reference solution and the sample solution, injecting into liquid chromatograph, and measuring.
Glycyrrhizin and glycyrrhizic acid
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; 0.1% phosphoric acid water is used as a mobile phase A, and acetonitrile is used as a mobile phase B; detection wavelength: 237 nm; the theoretical plate number is not less than 3000 calculated according to liquiritin peak; flow rate: 0.8 ml/min; column temperature: at 30 ℃. Gradient elution is shown in the following table.
Mobile phase gradient elution table
Preparation of control solutions: precisely weighing appropriate amount of liquiritin and ammonium glycyrrhizinate reference substance, and adding methanol to obtain solutions containing liquiritin 10 μ g and ammonium glycyrrhizinate 200 μ g per 1 ml.
Preparation of a test solution: grinding XINXIEBAISAN composition (sieving with No. three sieve), weighing about 0.20g, precisely weighing, placing in 50ml conical flask, adding 10ml 50% methanol for dissolving, weighing, ultrasonic dissolving, cooling, adding to balance weight, shaking, collecting solution, centrifuging, collecting supernatant, filtering, and collecting filtrate.
The determination method comprises the following steps: precisely sucking 10 μ L of each of the reference solution and the sample solution, injecting into liquid chromatograph, and measuring.
Wogonin B
Chromatographic conditions and systematic testing: BEH Shield RP18 (2.1X 100mm, 1.7 μm); column temperature: 30 ℃; flow rate: 0.2 mL/min; mobile phase: acetonitrile (a) -0.1% phosphoric acid water (B); the gradient elution conditions are shown in the following table, and the number of theoretical plates is not less than 1000 calculated according to the lycium barbarum B.
Mobile phase gradient elution table
Preparation of control solutions: precisely weighing appropriate amount of wogonin B reference substance, and adding methanol to obtain solution containing wogonin B250 μ g per 1 ml.
Preparation of a test solution: grinding the Xinxiebai powder composition (sieving with a third sieve), precisely weighing about 0.50g, adding 15mL of water for dissolving, putting 1mL of the dissolved solution into a centrifuge tube, carrying out 13000r/min, centrifuging for 5min, taking the supernatant, and sieving with a 0.22 mu m microporous filter membrane to obtain the Xinxiebai powder composition.
The determination method comprises the following steps: precisely sucking 1 μ L of each of the sample solution and the reference solution, injecting into a liquid chromatograph, and measuring.
The chromatograms are shown in FIGS. 1-3. Through detection, the traditional Chinese medicine composition in the example 1 contains not less than 18mg/g of mulberroside A, not less than 12mg/g of lycium barbarum B, not less than 1.8mg/g of liquiritin and not less than 3.5mg/g of glycyrrhizic acid.
Examples of the experiments
1. Antitussive effect
Experimental Material
(1) Experimental animals: SPF-level Kunming mice, male and female, body weight 20-24 g; the breeding temperature is 20-22 ℃, and the relative humidity is about 52%.
(2) The main apparatus is as follows: BS224S electronic balance, mouse stomach-filling needle, cough-inducing asthma-inducing device (YLS-8A)
(3) Drugs and reagents: xiebai san original technology group (clinical equivalent dose); new purgative powder compositions (clinical equivalent dose); bulbus Fritillariae Cirrhosae et folium Eriobotryae syrup: 150 ml/bottle, Guangxi Bangqi pharmaceuticals, Inc.; ammonia, jin dong tianzheng fine chemical plant, Tianjin city; physiological saline, jilin province, tomayu pharmaceutical industries, ltd.
The new Xiebai powder composition is dissolved by 10 times of deionized water and is used for gastric lavage.
The original process of the Xiebai san is as follows: weighing (fried) cortex mori, 39.3g cortex lycii radicis and (baked) liquorice, 3.9g liquorice, and 15g polished round-grained rice, wherein the three decoction pieces are crushed and sieved by a sieve of 10 meshes. Adding 3600ml of water, decocting with strong fire (500W), boiling, decocting with slow fire (300W) for 20min until seven minutes of decoction remains, filtering with 300 meshes while hot, concentrating the filtrate, and drying to obtain the final product.
The experimental method comprises the following steps: taking Kunming mice (22g +/-2): 20 male mice and 20 female mice were randomly divided into 4 groups, i.e., a blank control group, a Xiebai powder original technique group, a Xinebai powder composition group (prepared by the method of example 1), and a Chuanbei loquat syrup group (5.8ml/kg), according to sex. Each group is 10, respectively administered by intragastric administration, the bulbus fritilariae loquat dew group is 5.8ml/kg, the blank control group is administered with physiological saline with the same volume, the original Xiebai powder technical group and the new Xiebai powder composition group are respectively administered with the clinical equivalent dose of intragastric administration for 1 time every day for 8 days continuously, 1 hour after the last administration, mice are respectively put into a cough inducing and asthma inducing instrument one by one according to the groups, ammonia water with the concentration of 5 percent is sprayed in, the mice are stimulated to cause cough (the cough index is the abdomen contraction, the chest contraction, the head raising, the mouth opening or the cough), the cough incubation period (the time from the beginning of timing to the appearance of the cough index) of the mice and the cough frequency (the cough is measured by abdominal muscle contraction and the opening of the large mouth at the same time) within 3 min.
Statistical analysis: using Excel software to input data and establishing a database, and averaging the data plus or minus standard deviation
The results of the comparisons between groups were examined by homogeneity of variance and by One-way ANOVA, the repeated measures were analyzed by variance, and the multiple comparisons were performed by the LSD method. All data statistics and analysis are completed by SPSS 19.0 software, and P <0.05 represents statistical significance.
The experimental results are as follows: the antitussive effect of the original Xiebai powder process and the Xinxiebai powder composition on mice is shown in Table 1-1.
TABLE 1-1 antitussive effect of XIEBAISAN extract and XINXIEBAISAN composition on mice
Note: p <0.05, P <0.01, compared to the blank control group
The experimental results show that compared with the blank control group, the original Xiebai powder process group and the new Xiebai powder composition group can obviously prolong the cough latent period of the mice (P <0.01) and obviously inhibit the cough frequency of the mice (P < 0.01). The new Xiebai powder composition has a certain effect of relieving cough.
2. Relieving asthma
Experimental Material
(1) Experimental animals: guinea pig, male and female, weight 190-; the breeding temperature is 20-22 ℃, the relative humidity is about 52%, and the feed is used for experiments after being stably fed for one week.
(2) The main apparatus is as follows: BS224S electronic balance, mouse stomach-filling needle, cough-inducing asthma-inducing device (YLS-8A)
(3) Drugs and reagents: xiebai san original technology group (clinical equivalent dose); new purgative powder compositions (clinical equivalent dose); cough syrup oral liquid: 180 ml/bottle, Shaanxi step size pharmaceutical Co., Ltd; sodium bicarbonate solution, shanghai source leaf biotechnology limited; normal saline, jilin province, tomaythic pharmaceutical limited; acetylcholine, Shanghai-derived leaf Biotech limited; histamine phosphate, shanghai wangbo biotechnology ltd.
The new Xiebai powder composition is dissolved by 10 times of deionized water and is used for gastric lavage.
The experimental method comprises the following steps: the method comprises the steps of taking a guinea pig with the weight of 190-210g, putting the guinea pig into a cough and asthma inducing instrument, continuously spraying a mixed solution of 2% of acetylcholine chloride (Ach) and 0.1% of histamine phosphate in equal amount for 20s for pre-selection, observing the sudden breathing, the convulsion and the tumbling time of the guinea pig after spraying is stopped, wherein the guinea pig with the latency period of more than 150s is insensitive and unusable, and the tumbling time of less than 150s is taken as a qualified guinea pig with asthma.
Selecting guinea pigs with pre-selected qualified weights (190-210 g) the following day: 20 male mice and 20 female mice were randomly divided into 4 groups, i.e., a blank control group, a Xiebai powder original technique group, a Xinebai powder composition group (prepared by the method of example 1), and a Kelu oral liquid group, according to gender. Each group comprises 10 Chinese medicinal herbs, the stomach administration is carried out respectively, the cough syrup oral liquid group is 4.6ml/kg, the blank control group is administered with physiological saline with the same volume, the original Xiebai powder group and the new Xiebai powder composition group are respectively administered with the stomach administration clinical equivalent dose, the administration is carried out for 1 time every day for 8 days continuously, 1 hour after the last administration, 1 Chinese medicinal herb is put into a cough-inducing asthma-inducing instrument every time, the same-amount mixed liquid of 2 percent of acetylcholine chloride (Ach) and 0.1 percent of histamine phosphate is sprayed continuously for 30s, the asthma-inducing incubation period of the guinea pig is observed, and the time from the beginning of spraying to the occurrence of asthma reaction (the occurrence of dyspnea, the face scratching of the forepaws, the body inclination.
Statistical analysis: using Excel software to input data and establishing a database, and averaging the data plus or minus standard deviation
The results of the comparisons between groups were examined by homogeneity of variance and by One-way ANOVA, the repeated measures were analyzed by variance, and the multiple comparisons were performed by the LSD method. All data statistics and analysis are completed by SPSS 19.0 software, and P <0.05 represents statistical significance.
The experimental results are as follows: the original extraction process of Xiebai powder and the results of the antiasthmatic action of the novel Xiebai powder composition on Guinea pigs are shown in Table 2-1.
TABLE 2-1 Experimental results of the antiasthmatic effect of the original Xiebai powder extract and the Xiebai powder composition on guinea pigs
Note: p <0.05, P <0.01, compared to the blank control group
The experimental results show that compared with the blank control group, the original Xiebai powder process group and the new Xiebai powder composition group can obviously prolong the asthma-inducing incubation period (P <0.01), which indicates that the new Xiebai powder composition has a certain asthma-relieving effect.
Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A Chinese medicinal composition comprises or consists of 4-8 weight parts of parched cortex Mori extract, 1-3 weight parts of radix Glycyrrhizae Preparata extract and 2-6 weight parts of baked cortex Lycii extract, wherein in the composition, mulberroside A is not less than 18mg/g, lycin is not less than 12mg/g, liquiritin is not less than 1.8mg/g, and glycyrrhizic acid is not less than 3.5 mg/g.
2. The Chinese medicinal composition according to claim 1, wherein the parched cortex Mori extract is parched cortex Mori ethanol extract, the radix Glycyrrhizae Preparata extract is radix Glycyrrhizae Preparata ethanol extract, and the baked cortex Lycii extract is baked cortex Lycii water extraction and ethanol precipitation extract.
3. A method of preparing the traditional Chinese medicine composition of claim 1 or 2, comprising: respectively processing cortex Mori, cortex Lycii and Glycyrrhrizae radix to obtain parched cortex Mori, baked cortex Lycii and radix Glycyrrhizae Preparata; taking fried cortex Mori 10-15 weight parts, baked cortex Lycii 10-15 weight parts, and radix Glycyrrhizae Preparata 1-2 weight parts to prepare extracts of fried cortex Mori, baked cortex Lycii and radix Glycyrrhizae Preparata; mixing the three extracts at a certain proportion to obtain the Chinese medicinal composition.
4. The method as claimed in claim 3, wherein the processing technique for parching cortex Mori comprises: washing cortex Mori with water, moistening with water, slicing, air drying, parching at 120 deg.C for 30-80min at 110-;
preferably, the processing technology of the cortex lycii radicis comprises the following steps: washing fresh cortex Lycii with water, filtering with coarse cloth, stirring, slicing to obtain cortex Lycii decoction pieces, and drying at 30-50 deg.C and 30-50% humidity;
preferably, the processing technology of the honey-fried licorice root comprises the following steps: moistening Glycyrrhrizae radix with water, slicing, air drying, diluting refined Mel with water, mixing with the above medicinal materials, moistening, parching at 80-120 deg.C to yellow to dark yellow, taking out when it is not sticky, and air cooling;
preferably, the preparation method of the fried white mulberry root-bark extract comprises the following steps: pulverizing parched cortex Mori into 0.3-0.5cm coarse particles, adding 70% ethanol, reflux-extracting for 2 times, adding 6-10 times of 70% ethanol for the first time, heating to boil, maintaining slight boiling at 80-100 deg.C for 1-2 hr, filtering, adding 4-8 times of 70% ethanol for the second time, heating to boil, maintaining slight boiling at 80-100 deg.C for 0.5-1.5 hr, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying to obtain the final product;
preferably, the preparation method of the honey-fried licorice extract comprises the following steps: taking radix Glycyrrhizae Preparata, coarsely crushing into coarse particles of 0.3-0.5cm, adding 50% ethanol, reflux-extracting for 2 times, adding 6-10 times of 50% ethanol for the first time, heating to boil, keeping slight boiling at 90-120 deg.C for 1-2h, filtering, adding 6-8 times of 50% ethanol for the second time, heating to boil, keeping slight boiling at 90-120 deg.C for 0.5-1.5h, filtering, mixing filtrates, recovering ethanol, concentrating to specific gravity of 1.05-1.08 (measured at 50 deg.C), centrifuging at 4000r/min for 10min, collecting supernatant, and drying to obtain the final product;
preferably, the preparation method of the cortex lycii radicis extract comprises: taking cortex lycii radicis to be coarsely broken into coarse particles, adding water for reflux extraction for 2 times, adding 8-12 times of water for heating reflux for 1-2h for the first time, filtering, adding 6-10 times of water for heating reflux for 0.5-1.5h for the second time, filtering, combining filtrates, concentrating under reduced pressure at 50-65 ℃ until the specific gravity is 1.10-1.15 (measured at 50 ℃), placing at room temperature, adding 3 times of ethanol, stirring for 0.5h, standing for 12h, taking supernatant, recovering ethanol, continuously concentrating until the specific gravity is 1.05-1.08 (measured at 50 ℃), centrifuging for 10min at 4000r/min, taking supernatant, and drying to obtain the traditional Chinese medicine.
5. A pharmaceutical preparation comprising the Chinese medicinal composition as claimed in claim 1 or 2 as an active ingredient;
preferably, the pharmaceutical preparation is oral liquid, pellets, granules or tablets.
6. The pharmaceutical formulation of claim 5, which is an oral liquid comprising or prepared from the following raw materials: the traditional Chinese medicine composition of claim 1 or 2, which comprises 7-15 wt% of anhydrous citric acid, 0.1-0.2 wt% of anhydrous citric acid, 0.009-0.015 wt% of neotame and 85-92 wt% of water, wherein the sum of the weight percentages of the raw materials is not more than 100%.
7. The pharmaceutical formulation of claim 5, which is a pellet comprising or prepared from: the traditional Chinese medicine composition of claim 1 or 2, 35-45 wt%, microcrystalline cellulose 25-40 wt%, sodium carboxymethyl starch 10-25 wt%, and ethanol.
8. The pharmaceutical preparation according to claim 5, which is a granule comprising or prepared from the following raw materials: the Chinese medicinal composition of claim 1 or 2, which comprises 60-80 wt% of sucrose aqueous solution with concentration of 10% and 20-40 wt%.
9. The pharmaceutical formulation of claim 5, which is a tablet comprising or prepared from: 30-48 wt% of the traditional Chinese medicine composition of claim 1 or 2, 20-35 wt% of xylitol, 25-40 wt% of powdered sugar and 0.5-1 wt% of magnesium stearate, wherein the sum of the weight percentages of all the raw materials is not more than 100%.
10. Use of a Chinese medicinal composition as claimed in claim 1 or 2 or a pharmaceutical formulation as claimed in claims 5 to 9 in the manufacture of a medicament for the treatment of cough with dyspnea due to lung heat.
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